| CTRI Number |
CTRI/2021/10/037074 [Registered on: 04/10/2021] Trial Registered Prospectively |
| Last Modified On: |
25/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Diode Laser and Photodynamic therapy as an adjunct to Scaling and Root Planning in the treatment of Chronic Periodontitis: A Randomized Clinical trial.
|
|
Scientific Title of Study
|
Clinical efficacy of Diode Laser and Photodynamic therapy as an adjunct to Scaling and Root Planning in the treatment of Chronic Periodontitis: A Randomized Clinical trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prathipaty Rini Jyothsna |
| Designation |
Postgraduate student |
| Affiliation |
Sree Sai Dental College and Research Institute |
| Address |
sree sai dental college and research institute chapuram village balaga rural srikakulam Andhra pradesh India
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8919689937 |
| Fax |
|
| Email |
jessyrini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K ANIL KUMAR |
| Designation |
HOD and PROFESSOR |
| Affiliation |
Sree Sai Dental College and Research Institute |
| Address |
sree sai dental college and research institute chapuram village balaga rural srikakulam Andhra pradesh India
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rini Jyothsna |
| Designation |
Postgraduate student |
| Affiliation |
Sree Sai Dental College and Research Institute |
| Address |
sree sai dental college and research institute chapuram village balaga rural srikakulam Andhra pradesh India
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8919689937 |
| Fax |
|
| Email |
jessyrini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Sai Dental College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Prathipaty Rini Jyothsna |
| Address |
Sree Sai dental college & research institute Chapuram village
balaga rural
srikakulam .
pincode 532001.
Andhra pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rini Jyothsna |
Sree Sai Dental College and Res Institute |
Department of Periodontics Room no 8 Chapuram, Balaga Rural, Srikakulam
Srikakulam
ANDHRA PRADESH |
8919689937
jessyrini@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic periodontics |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil only scaling and root planing |
Nil only ultra sonic scaling and root planing |
| Intervention |
photodynamic therapy using Toluidine blue O 0.01%.
Diode laser 660nm. |
comparison between scaling and root planning, photodynamic therapy using Toluidine blueO dye 0.01%, diode laser 660nm, 0.6W will be administered in 3 different quadrants. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals.
Probing depth of 4 - 6 mm in 3 different quadrants of the mouth.
|
|
| ExclusionCriteria |
| Details |
Smokers and alcoholics.
Pregnant and Lactating women.
Medically compromised patients.
History of Antibiotic therapy from the past 6 months.
History of Periodontal treatment from the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of Diode laser and photodynamic therapy with scaling and root planning in the management of Periodontitis |
3months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Diode Laser along with Scaling and Root Planning in the management of periodontitis.
To evaluate the effectiveness of Photodynamic therapy along with scaling and root planning in the management of Periodontitis.
|
3months, 6months |
|
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Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, controlled clinical trial a split-mouth design comparing the clinical efficacy of scaling & root planning, diode laser 660nm, photodynamic therapy using Toluidine blue ’O’ dye in the management of periodontitis that will be conducted in sree sai dental college and research institute, Srikakulam. A total of 15 patients will be
included in a split-mouth design. After
obtaining informed consent, the patients will be randomly allocated into
three groups. Group 1will receive
scaling and root planing alone, Group 2 will receive SRP along with Diode
laser irradiation, Group 3 will receive SRP along with Photodynamic Therapy. Scaling and root planing
will be done under LA using hand instruments followed by oral hygiene
instructions. Diode Laser
irradiation with a wavelength of 660nm, a power output of 0.6W will be applied
in the selected quadrant, and each selected
site will be irradiated for 10 secs. Photodynamic therapy
- The selected sites will be rinsed with a photosensitizer (Toluidine blue ‘O’
0.01%) employing a blunt cannula; excess photosensitizer is removed after one
minute, followed by laser irradiation |